IRBs and research institutions continue to hammer out processes and best practices related to the revised Common Rule. As one IRB found, this process requires a team effort.
When collaborative IRB requests began to increase, the Augusta (GA) University IRB office formed a reliance team. The IRB also designated one team member, a reliance coordinator, to handle issues related to reliance agreements.
A recent study revealed the reliance team helps IRB offices with collaboration and reviewing reliance agreements to ensure the research is in accordance with local policies. The team also can help investigators navigate through reliance process.1
The purpose of the team approach is to enable investigators, IRB staff, and others in the human research enterprise to learn as the reliance process evolves, says Ivy Tillman, MS, CCRC, CIP, Augusta University IRB office director.
“We want to make sure that any reliance agreement the university enters into — whether as a relying IRB or reliance institution — would first [comply] with our institution’s policies,” Tillman says.
The reliance process is supposed to make the IRB process move faster. Relying IRBs also need to address any problems pertaining to their internal IRB. For example, the relying IRB may want to know who is conducting the cognitive assessment, how it works, and documentation that qualified people are conducting it, for a study that enrolls people with limited capacity, Tillman explains. Even when people are relying on another IRB, it is important to make sure researchers are qualified to do what their study expects them to do.
“Every IRB is different, has different requirements,” says Tiffany Coleman, MS, MPH, CIC, CIM, CIP, reliance coordinator at Augusta University. “We wanted to add a spectrum of support to our research. There are a lot of questions [in building a reliance agreement], and we have to learn the policies and procedures of these external IRBs.”
Reliance work includes sending information to researchers and ensuring they are in compliance with the other IRB. “Researchers have to read policies and procedures for this other IRB, but we also go over that with them,” Coleman says.
For example, investigators should understand the IRB of record’s reportable events policy. “They need to report to both IRBs, depending on the event,” Tillman says.
Create an Effective Process
Here are more ways to ensure an effective reliance process:
• Hold a study start-up meeting. After finalizing the reliance agreement, the study coordinator and reliance team can meet to review their responsibilities at the local institution.
Some of this information includes asking investigators to report to the relying IRB, as well as the IRB of record, any changes in the consent document. “We go over the regulatory aspect, saying they could be audited and not just by Augusta University, but also by the outside IRB,” Coleman says. “If there are any nuances with the external IRB, we go over that.”
For instance, the relying IRB may require study personnel changes to be reported to the IRB, while the reliance IRB does not require that information.
Before the COVID-19 pandemic, these start-up meetings were held in person at the IRB office. After the pandemic forced shutdowns, the meetings took place virtually, usually lasting about an hour, Coleman says.
• Create a strong communication process. “We created an IRB reliance mailbox, where we get so much communication,” Coleman says. “We also launched our collaborative research website, which is a hub of information for reliances and dealing with an external IRB.”
The IRB also created a reliance request form, which is a four- to five-page PDF that summarizes the study, lists information on the local investigator, and how the institution will be engaged in research. “It’s a big synopsis of the study, including approved documents of the study,” Coleman says.
Researchers need to submit their study protocol to the IRB of record, but also should submit study information into the relying IRB’s electronic system. “Even though we’re not reviewing the IRB, we do require a submission in our electronic database so we have a document of the research here,” Coleman explains. “They have to physically submit it to our system and download the documents.”
It is important to bring the lead investigator and all study sites to the table to ensure they know what the IRB expects.
“Lead investigators may have their own communication plan with sites, and we confirm this to make sure the sites know [what to expect],” Tillman explains. “If there’s a reportable event, we tell them what we expect, and we walk through our expectations to make sure they’re clear.”
- Coleman T, Tillman I. Working through the revised Common Rule: sIRB. Presented at the PRIM&R Advancing Ethical Research Virtual Conference, held Dec. 1-2, 8-9, and 15-16, 2020. Poster/Abstract: 32.